Salvatore J. Salamone, PhD

The standard of care in dosing chemotherapeutic agents is based on body surface area — or BSA. The BSA-based dose for any given drug is recommended by the manufacturer according to the maximum tolerated dose established during phase 1 studies. MTD, in turn, is generally determined using the Fibonacci dose escalation “3 + 3 schema” in which three patients are enrolled at each proposed dose level and if one patient experiences a drug limiting toxicity, three additional patients are then enrolled at that same dose level. If two or more additional patients at a particular dose level present a drug limiting toxicity, enrollment of patients to that dose level is discontinued and the immediate preceding dose level is considered the MTD.